Sr Manager, PV Science

This role is considered Hybrid.

The Associate Director, PV Science is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. Will oversee risk management plan activities including signal tracking maintenance, adhoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Alnylam products.

Summary of Key Responsibilities

• Works closely with the safety physician to analyze potential safety issues, including signal detection, signal evaluation and signal management.  Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
• Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
• Develop knowledge of capabilities and limitations of various data sources.  
• Assist in the evaluation of potential safety issues and quality risk assessment reports.
• Contribute to activities related to the functioning of Alnylam safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues. 
• Together with safety physician and more senior PV scientists assist in managing/supporting  the authoring for aggregate safety reports (eg.PSUR, DSUR, Line listings) in close collaboration with the safety product lead and operational functions
• Supports all SRMT preparation and documentation with guidance from mentor and safety physician

Qualifications

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Education: Degree in a medical or healthcare related discipline (MSN, PharmD, PA, MD,), or high qualification relevant to scientific or business discipline.

Experience: A minimum of 2-4 years in the pharmaceutical industry with experience in drug safety/pharmacovigilance.

Strong skills and experience in;

• Support the development and application of business process improvement methodologies and/or developing ideas into practical business solutions.
• Ability to work in a matrix environment in accordance with the company leadership commitments and values. Preferably with experience of working across diverse geographic areas, business settings and cultures.
• Pharmacovigilance, safety or clinical science, and/or other relevant areas of clinical biopharmaceutical development or medical affairs.
• Knowledge of Argus, Arisg Safety Databases
• Knowledge of Signaling tools (eg. Empirica, Spotfire)
• Experience and or understanding of regulations in the pharmaceutical industry.
• Skills in developing/implementing data displays (Dashboards) of data for signaling, compliance and departmental KPIs & QPIs
• Knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
• Strong planning, organization, written and oral communication skills
• Experience in clinical patient care a plus

Special Skills: Ability to represent the functional department as internal and external contact on contracts and delivery for services relating to drug safety risk management.  Manage cross-functional briefings and technical meetings for project stakeholders and customer representatives.  Negotiation skills encouraging discussion and driving decisions to desired results.  Strong analytic and scientific writing abilities. 

Job Complexity:  Involved Aggregate Report Management and in RMP across the product life cycle. Managing through cross-functions, business partners and CROs. Responsible for the successful implementation and management of activities contributing to risk management. 

Supervision:  Individual is expected to work independently with support from management and colleagues in GPSRM.
 

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.